A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?
The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.
Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.
The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who are ≥18 years of age at time of consent.
- •Post-lingual, bilateral, moderate to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
- •Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:
- •≤70 dB HL at 125, 250, and 500 Hz; AND
- •≥70 dB HL at 2000, 4000, and 8000 Hz.
- •Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant.
- •Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.
排除标准
- •Current, or within 60 days prior to study consent, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
- •Participation in another investigational drug or device study within 90 days prior to study consent.
- •Female patients who are pregnant or breastfeeding.
- •Moderate or severe hepatic impairment using Child-Pugh Score (>6 points).
- •No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant.
- •No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).
研究组 & 干预措施
Placebo
Oral administration of matching placebo BID for 180 days
干预措施: Placebo (Drug)
SPI-1005 400 mg twice daily (BID)
Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days
干预措施: Ebselen (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (TEAE)
时间窗: 12 months
Number and severity of adverse events in patients treated with placebo versus SPI-1005. Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.
次要结局
未报告次要终点